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510(k) Data Aggregation

    K Number
    K133881
    Device Name
    MACY CATHETER
    Manufacturer
    Date Cleared
    2014-01-24

    (35 days)

    Product Code
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    HOSPI CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Macy Catheter is intended to provide rectal access to administer liquids/medications.
    Device Description
    The Macy Catheter has been designed for comfort and safety by utilizing a flexible silicone body that enables administration of liquids/medications to the rectum. The device has two lumens, one for administering the liquids/medications and the other for inflation of the retention balloon. The catheter is inserted into the rectum and a small, soft retention balloon is inflated with water via the inflation valve. Liquids/medications are delivered via the medication valve, through the catheter, and into the rectum. The retention balloon can be easily deflated for removal of the catheter. The Macy Catheter remains in the recturn until expelled upon defecation (or removed for defecation if the patient prefers).
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